1. Field of the Invention
The present invention relates to a holder for use with dual end needle assemblies commonly used in blood collection procedures. More particularly, the present invention relates to a needle holder for use with a safety needle for blood collection from a patient and which includes a mechanism for activating the safety feature of the needle.
2. Description of Related Art
Disposable medical devices having piercing elements are typically used for administering a medication or withdrawing a fluid, such as blood collecting needles, fluid handling needles and assemblies thereof. Current medical practice requires that the fluid containers and needle assemblies used in such systems be inexpensive and readily disposable. Consequently, existing blood collection systems, for example, typically employ some form of durable, reusable holder on which detachable and disposable needles and fluid collection tubes may be mounted. A blood collection system of this nature can be assembled prior to use and then disassembled after usage. Thus, these blood collection systems allow repeated use of the relatively expensive holder upon replacement of the relatively inexpensive needle and/or fluid collection tube. In addition to reducing the cost of collecting blood specimens, these blood collection systems also help minimize the production of hazardous medical waste.
A popular design configuration of previously available blood collection systems includes a double-ended needle assembly, an evacuated collection tube, and a holder for maintaining the needle assembly and the collection tube in fixed relation. The double-ended needle assembly, which is also referred to as a cannula, has a bore extending therethrough and a hub near a central region thereof. The evacuated fluid collection tube includes a puncturable stopper at one end thereof. In this type of blood collection system, the holder typically has a housing at one end thereof for receiving the needle assembly. Likewise, the holder also has a hollow body with an opening at an opposite end thereof for receiving the collection tube. The needle assembly is rigidly received within the housing of the holder such that a first end of the needle extends forwardly of the holder for puncturing the vein of a patient. The opposite, second end of the needle extends into the hollow body of the holder. Upon assembly of the blood collection system, the needle assembly is inserted into the housing and the collection tube is inserted through the open end of the hollow body until the second end of the needle pierces the puncturable stopper of the collection tube, thereby allowing fluid communication between the interior of the collection tube and the bore which extends through the needle assembly. To draw a blood specimen from a patient using one of these blood collection systems, the evacuated collection tube is partially inserted into one end of the holder, the first end of the needle is inserted into a patient""s vein and the collection tube is fully inserted into the holder such that blood will be drawn through the bore of the needle assembly and into the fluid collection tube. After drawing the specimen, the collection tube is removed so that the blood contained therein can be analyzed and the needle assembly is detached for disposal.
In addition to being capable of accommodating blood collection tubes, the holders of some fluid transfer systems are compatible with fluid containers having a fluid to be injected into a patient. Thus, such holders can be used to inject fluid into, as well as draw blood specimens from, a patient.
In order to reduce the risk of incurring an accidental needle-stick wound, protection of the used needle tip becomes important. With concern about infection and diseases of the blood, methods and devices to enclose the used disposable needle have become very important and in great demand. Many developments have taken place for protecting used needle tips. For example, U.S. Pat. No. 5,951,520 to Burzynski et al., discloses a self-blunting needle in which a rod or probe-like blunting member is disposed within the bore of a needle cannula having a puncture tip suitable for puncturing tissue. To prevent accidental needle-stick wounds from occurring after use of the device, the blunting member, which is retracted behind the puncture tip when the needle is injected into tissue, can be extended beyond the puncture tip of the needle cannula to effectively blunt the puncture tip by extending beyond it, so as to eliminate or at least greatly reduce the risk of accidental needle-stick punctures.
U.S. Pat. No. 5,810,775 to Shaw discloses a collection assembly which provides for retraction of the intravenous needle at the patient end of the assembly, and further discloses a hinged cap at the open end of the housing of the holder. After drawing a specimen into a collection tube, the collection tube is removed, and the hinged cap is closed over the opening of the holder, thereby activating the needle retraction and blocking access to the second end of the needle at the non-patient end. Activation of the hinged cap and the retraction mechanism requires substantial manipulation by the user and cannot be conveniently accomplished with a single hand, as is ideal for typical phlebotomy practice. Furthermore, the size of the device is relatively large, and the retraction mechanism for the needle can cause splattering of blood when the tip of a used needle is accelerated during retraction, thus potentially exposing health care workers to blood borne pathogens.
Accordingly, a need exists for a needle holder which can be used with a needle assembly which can be activated for safety blunting of the needle which is simple to manufacture, easy to operate, and does not occupy a significant amount of disposal space.
The present invention is directed to a needle holder for use in combination with a needle assembly which includes an activation mechanism adapted for axial displacement between a first position and a second position with respect to the needle assembly through engagement with a blood collection tube. The needle holder includes an outer body having a first end adapted for attachment to the needle assembly and a second end having an internal opening therein for accommodating a blood collection tube for engagement with the needle assembly. The needle holder further includes a lever which is movable between a first blocking position in which an activation mechanism of the needle assembly is blocked from engagement with the blood collection tube to prevent axial movement from the first position to the second position, and a second release position in which the activation mechanism is capable of engagement with the blood collection tube to permit axial movement between the first position and the second position.
Desirably, the outer body includes a hinge for providing the lever as movable between the first blocking position and the second release position. Further, the outer body and the lever may be integrally formed and interconnected through the hinge.
The lever may further include an extension arm which extends within the internal opening of the needle holder for engagement with the blood collection tube. The extension arm is adapted for engagement with a stopper of the blood collection tube. Desirably, the lever extends along a portion of the outer body of the needle holder and the extension arm extends through the outer body of the needle holder within the internal opening thereof. Also, the lever may include a tab for moving the lever between the first blocking position and the second release position. Alternately, the needle holder may include a first lever and a second lever extending along opposing sides of said outer body of the needle holder.
In a further embodiment, the present invention is directed to a blood collection assembly which includes a needle holder as described above attached to a needle assembly, with the needle assembly having an activation mechanism which is adapted for axial displacement between a first position and a second position with respect to the needle assembly through engagement with a blood collection tube.
In yet a further embodiment, the present invention is directed to a safety collection assembly which includes a needle holder attached to a safety needle assembly. The safety needle assembly includes an intravenous puncture tip, a non-patient puncture tip, and a blunting member having a blunted tip, with the blunting member adapted for axial displacement with respect to the intravenous puncture tip between a first retracted position in which the intravenous puncture tip extends beyond the blunted tip and a second activated position in which the blunted tip extends beyond the intravenous puncture tip. The needle holder is attached to the needle assembly and includes an outer body having an internal opening therein which is adapted for accommodating a blood collection tube for engagement with the non-patient puncture tip of the needle assembly and for axial displacement of the blunting member with respect to the intravenous puncture tip. The needle holder includes a lever which is movable between a first blocking position in which the blood collection tube is prevented from causing axial displacement of the blunting member with respect to the intravenous puncture tip and a second release position in which the blood collection tube is permitted to cause axial displacement of the blunting member with respect to the intravenous puncture tip. Desirably, the needle assembly further includes a second blunted tip adjacent the non-patient puncture tip, and axial displacement of the blunting member with respect to the intravenous puncture tip between the first retracted position and the second activated position also causes axial displacement of the non-patient puncture tip with respect to the second blunting tip between a first retracted position in which the non-patient puncture tip extends beyond the second blunted tip and a second activated position in which the second blunted tip extends beyond the non-patient puncture tip.